NCT03752736

Brief Summary

The overarching goal of this work is to pilot-test a song-based instructional video designed to help elementary school (kindergarten) age children independently apply sunscreen effectively (i.e., covers all needed areas), efficiently (i.e., can be accomplished in 2-3 minutes), consistently (i.e., continues to apply sunscreen routinely before recess both during and after the intervention), without impacting classroom function (i.e., no mess). The video is also designed to encourage use of hats and sunglasses. The outcomes of interest include identification of "gaps" in skills that are consistent for this age group (i.e., commonly miss application to the back of neck), areas of learning refinement (i.e., generalization of skills with different outfits on), and flexibility in terms of adapting practice (i.e., can they do it without the video). The investigators hope that this pilot project will pave the way for broader clinical / educational implementation of this intervention within schools.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

October 16, 2018

Last Update Submit

August 10, 2019

Conditions

Keywords

SunscreenSun protectionEducationskin cancerschool-aged childrenprevention

Outcome Measures

Primary Outcomes (1)

  • Teacher Ratings of Kinder Students' Successful/Not Successful Self-Application of Sunscreen.

    Change in the proportion of kindergarten students who successfully complete independent self-application of sunscreen within the allotted 2.5 minute time window from baseline (Time 1) to posttreatment (Time 2). Successful completion of the sun screen task (i.e., Kinder Students' self-application of sunscreen within the 2.5 minute window allotted by the intervention) will be determined via direct observation by the classroom teacher. Teachers will be formally trained by the study staff to rate student performance (i.e., successful/not successful) with self-application of sunscreen per a manualized study protocol.

    Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)

Secondary Outcomes (4)

  • Teacher Identified Barriers to Kinder Student Self-Application of Sunscreen

    Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)

  • Teacher, parent and administrator perceptions of intervention utility.

    Posttreatment (Time 2; up to 15 minutes)

  • Teacher, parent and administrator perceptions of intervention value.

    Posttreatment (Time 2; up to 15 minutes)

  • Student perceptions of intervention likability

    Posttreatment (Time 2; up to 15 minutes)

Study Arms (2)

Extended intervention

ACTIVE COMPARATOR

Upon completion of the two-week baseline period and two-week standard intervention period, the two classrooms assigned to the Extended intervention condition will receive the "I wear sunscreen everyday" song-based video intervention daily for two additional weeks.

Behavioral: "I wear sunscreen everyday" song-based video

Maintenance

NO INTERVENTION

The two classrooms assigned to the Maintenance condition will continue to receive a two- minute window for sunscreen application, but no "I wear sunscreen everyday" song-based video instruction. Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up assignment condition and will provide preliminary information about dosing and maintenance effects.

Interventions

All four classes (arms) will be shown (sitting on carpet, not participating) a 2-3 minute song-based video titled "I wear sunscreen everyday" in which they observe elementary age children applying sunscreen in a systematic fashion. Following the viewing, classes will be administered this video guided, song- based intervention while their teacher documents their independent participation using our classroom map data collection sheet.

Extended intervention

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • General education Kinder students (Sedgwick Elementary School in 2018-2019).
  • Child assent and parental consent are required to participate.

You may not qualify if:

  • Non-general education status;
  • significant medical, mental health and/or behavioral problem
  • child refusal of assent or parental refusal of consent;
  • known or identified allergy to ingredients in sunscreen;
  • moving out of the grade or school during the intervention or follow-up period;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sedgwick Elementary School

Cupertino, California, 95014, United States

Location

Related Publications (1)

  • Lee GH, Bae GH, Barnes LA, Pol-Rodriguez MM, Ransohoff KJ, Nord KM, Lu Y, Cannell B, Weitlauf JC. The Sunscreen for Kindergarteners (SKIN) Study trial protocol. Contemp Clin Trials. 2021 Aug;107:106480. doi: 10.1016/j.cct.2021.106480. Epub 2021 Jun 11.

MeSH Terms

Conditions

SunburnSkin Neoplasms

Condition Hierarchy (Ancestors)

Photosensitivity DisordersSkin DiseasesSkin and Connective Tissue DiseasesBurnsWounds and InjuriesNeoplasms by SiteNeoplasms

Study Officials

  • Kristin Nord, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 16, 2018

First Posted

November 26, 2018

Study Start

February 25, 2019

Primary Completion

April 11, 2019

Study Completion

May 23, 2019

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations